IRVINE, Calif. The Food and Drug Administration has rejected the approval application for a drug to treat colorectal cancer.
Spectrum Pharmaceuticals announced Friday that the FDA had rejected its application seeking an additional approval for the drug Fusilev (levoleucovorin), as a treatment for advanced colorectal cancer. The drug already has approval for treating the bone cancer osteosarcoma.
In its complete response letter – which signifies a rejection – the FDA said Spectrum had not demonstrated that Fusilev was equal to or better than leucovorin. The company said it will meet with the FDA to discuss options for obtaining approval for Fusilev as a colorectal cancer treatment.
Several companies market leucovorin as a generic in injectable and tablet form; GlaxoSmithKline originally marketed it under the brand name Wellcovorin, though it no longer sells the drug.